MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-14 for SNAPLINK BUCCAL TUBE manufactured by Ormco Corporation.
[3763375]
A doctor alleged that approximately twenty (20) patients had experienced the rotation of a lower first molar after the doors of the snaplink buccal tubes had broken. This is the seventh of twenty (20) reports.
Patient Sequence No: 1, Text Type: D, B5
[10935360]
Patient specifics with regard to gender, age, and weight were not provided by the doctor. Although the doctor identified two different snaplink catalog numbers associated with the rotation of the patient's molar, he could not verify which catalog number was used on the patient. The catalog numbers involved in the alleged incident include 438-2191 and 438-2190. The doctor replaced the patient's buccal tube, without further incident. To date, the patient is doing fine. The device involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2013-00083 |
| MDR Report Key | 3287373 |
| Report Source | 05 |
| Date Received | 2013-08-14 |
| Date of Report | 2013-08-06 |
| Date Mfgr Received | 2013-08-06 |
| Date Added to Maude | 2013-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SNAPLINK BUCCAL TUBE |
| Generic Name | ORTHODONTIC TUBE |
| Product Code | DZD |
| Date Received | 2013-08-14 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILLS AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-08-14 |